Insulin Syringe 3/10mL 29G x 1/2 328510Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00681131311663), received between Mar 19, 2018 and Mar 17, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT SYRINGE 0.3ML 29GA 12.7MM 10BAG 500 WAL WAS MISSING THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328510 BATCH NO: 5180853. IT WAS REPORTED NO EXPIRATION DATE ON A BOX OF RELION SYRINGES. VERBATIM: RELATIVE OF CONSUMER REPORTED NO EXPIRATION DATE ON A BOX OF RELION SYRINGES. STATED THE SYRINGES WERE PURCHASED IN 2015 AND SOME WERE USED. ADVISED THAT THIS PRODUCT BOX WOULD BE EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510052 ↗
• MalfunctionJun 2, 2020Device Markings/Labelling Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF RELION® INSULIN SYRINGES EXPERIENCED MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE RECEIVED FOR INTAKE: (B)(6) 2020 VERBATIM: BD MAIL FULFILLMENT HAS SEVERAL BOXES WITHOUT EXP DATE INFO ON THE BOXES. INFORMED FULFILLMENT TO DESTROY THE BOXES AND NOT SEND THEM OUT TO THE CONSUMERS FOR REPLACEMENT. ITEM # : 328510, LOT #S: 6195976.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10112233 ↗
• MalfunctionJan 29, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A DAMAGED STOPPER WAS FOUND DURING USE WITH A SYRINGE 0.3ML 29GA 12.7MM 10BAG 500 WAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PET OWNER INQUIRED TO FIND OUT WHERE CAN SHE CAN GET THE 29G, 12.7, 3/10ML SYRINGES. EXPLAINED WE NO LONGER MANUFACTURING IT AND IT HAS BEEN DISCONTINUED. SHE REPORTED IN THE PREVIOUS BOX, SHE COULD NOT PUSH THE PLUNGER ROD, WHEN SHE LOOKED AT THE STOPPER, IT WAS MISSHAPED. SAMPLE AVAILABLE -1." 7 OCCURRENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9644374 ↗
• MalfunctionAug 26, 2019Leak/Splash; Leak/Splash

  MATERIAL NO.: 328510. BATCH NO.: 6242636. IT WAS REPORTED THAT DURING USE OF THE RELION® INSULIN SYRINGE THE CONSUMER FOUND THAT MORE THAN ONE SYRINGE WITH SLANTED STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER FOUND MORE THAN 1 SYRINGE WITH SLANTED STOPPERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8930973 ↗
• MalfunctionAug 12, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT RELION® INSULIN SYRINGE PLUNGER ROD IS DIFFICULT TO MOVE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 328510, BATCH NO.: UNKNOWN. IT WAS REPORTED BY THE CONSUMER THAT THE PLUNGER ROD IS DIFFICULT TO MOVE. VERBATIM: CONSUMER REPORTED PLUNGER ROD DIFFICULT TO MOVE BEFORE INJECTION. PROBLEM OCCURRED A FEW MONTHS AGO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8883889 ↗
• MalfunctionMay 23, 2018Device Markings/Labelling Problem

  IT WAS REPORTED WITH THE USE OF THE BD¿ RELION® INSULIN SYRINGE W/NEEDLE THERE WAS AN ISSUE WITH THE SCALE MARKING. IT WAS STATED ¿THE SCALE MARKINGS WERE HARD TO SEE ESPECIALLY WHERE THE BLACK MARKING ARE AGAINST THE STOPPER THAT ARE ALSO BLACK.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7538279 ↗
• MalfunctionMar 19, 2018Material Deformation

  IT WAS REPORTED THAT THE STOPPER ON A BD¿ RELION® INSULIN SYRINGE WAS DEFORMED (DESCRIBED AS ¿CROOKED¿). THE SYRINGE WAS NOT USED AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7350112 ↗